Fluid separation devices, systems and/or methods using a centrifuge and roller pump

ABSTRACT

A centrifugal fluid separation system is disclosed for centrifugally separating a composite fluid into components thereof. This centrifugal separation system includes at least a centrifugal rotor which has a composite fluid containment area, a fluid flow channel/tubing and at least one separated component collection area defined therein. A composite fluid to be separated is delivered to the fluid containment area where under centrifugal forces the composite fluid is separated into components and then from which a component travels through an outlet channel to a respective separated component fluids flowing therethrough. A centrally disposed pump is also provided to move the separated component(s) to the collection area(s). Optical sensing of the interface of the separated fluid components may be used with a clamp to stop flow. A disposable bag and tubing system is also disclosed for use with reusable rotor devices.

RELATED APPLICATIONS

This case claims the benefit of priority of U.S. provisional patentApplication No. 60/372,574, filed Apr. 12, 2002.

INTRODUCTION

The present invention is directed generally to centrifugal fluidseparation devices and more particularly includes a roller pump drivenconfiguration usable with one or more disposable tubing and bag sets.

BACKGROUND OF THE INVENTION

In the United States, millions of units of donated whole blood arecollected by blood banks each year. Whole blood is made up of red bloodcells, white blood cells (also called leukocytes), and platelets, allsuspended in a protein-containing fluid called plasma. Because patientsare not likely to require each component of whole blood, most of thewhole blood collected from donors is not stored and used fortransfusion. Instead, the whole blood is separated into its clinicallytherapeutic components, red blood cells, platelets and plasma. Thecomponents are stored individually and used to treat a multiplicity ofspecific conditions.

A number of fluid separation devices have been known and various modelsare currently available for the separation of whole blood or othercomposite fluids into the various component elements thereof. Forexample, a variety of centrifugal machines are available for separatingblood into component elements such as red blood cells, platelets andplasma, inter alia.

Centrifugation in the past has been used for separation in many forms inboth continuous and batch types. For example, in the widely used processknown as continuous centrifugation, as generally opposed to batchprocess centrifugation, a continuous input of a composite fluid isflowed into the separation device or chamber while at the same time thecomponents of that composite fluid are substantially continuouslyseparated and these continuously separating components are usually thenalso substantially continuously removed therefrom. Many currentlypopular forms of such continuous fluid separation devices include loopsof entry and exit flow tubing lines connected to the separationcentrifuge chamber such that each loop is rotated in a relativeone-omega—two-omega (1ω–2ω) relationship to the centrifuge chamberitself so that the tubing lines will remain free from twisting aboutthemselves.

An alternative form of tubing line connection to a continuouscentrifugal separation device is also available in the art which doesnot have such a loop, but which instead requires one or more rotatingseals at the respective connections of the tubing lines to thecentrifuge separation chamber, again to maintain the tubing lines freefrom twisting.

Batch-type centrifugation, on the other hand, usually involvesseparation of a composite fluid such as whole blood in a closedcontainer, often a deformable bag, followed by removal of thecontainer/bag from the separation device and then subjecting thecontainer/bag to a relatively difficult process of automated and/ormanual expression of one or more of the separated components out of theseparation container or bag. A great deal of control, either automated,such as by optical interface detection, or by a diligent human operatorwatching a moving interface, is required with such previous batch-typeprocesses.

One type of known batch-type centrifuge uses buckets for holding bagsof, for example, whole blood collected from a donor. The buckets rotateto separate the components inside the bags. The bags are then removedfrom the centrifuge where they are expressed by an operator using amanual expressor to remove components from the bag. Another type ofcentrifugal apparatus that also functions as a cell washer is the COBE2991 system available from Gambro BCT, Inc., Lakewood, Colo. The COBE2991 as well as PCT International Publication No. WO01/97943 and U.S.Pat. No. 6,315,706 use an expresser fluid or hydraulic fluid forremoving separated components.

Indeed, various means and methods have been used in or with priorcentrifugal separation systems, both continuous and batch, for drivingfluid flow and maintaining desirable interface position control betweenthe component elements being separated thereby. For example, asmentioned, various optical feedback methods and devices have beenemployed in the art. Various pumping and valving arrangements have alsobeen used in various of these and other arrangements. Alternativerelatively automatic volume flow and density relationship interfacecontrols have also been used; for example, in a continuous system by thedisposition of control outlet ports in strategic locations relative tothe separated component outlet ports.

Nevertheless, many facets of these prior separation devices, thoughproviding heretofore-satisfactory production, may yield certain featureswhich are less efficient than a desired optimum. For example, forcollecting random donor platelets from whole blood it was necessary tohave a second spin and tighter control over the interface betweencomponents which in the past was difficult with a manual expresser.Another disadvantage of prior art systems is that frequently theinterface was required to move. For example, in hand or manualexpression, the interface moves during the component removal process.This can result in difficulties in maintaining the desired interface foroptimum collection.

Hence, substantial desiderata remain to provide a more highly efficientcentrifugal separation device particularly for whole blood in terms ofincreased efficiency fluid flow drive and separation interface controls;and/or reduced seal need and/or intricacy. It is toward any one or moreof these or other goals as may be apparent throughout this specificationthat the present invention is directed.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed generally to centrifugal fluidseparation devices and/or systems for use in centrifugally separatingwhole blood or composite fluids into the component elements thereof.Such centrifugal separation systems include centrifugal rotor androtor/fluid container combinations in which each rotor with one or aplurality of containers positioned therein, may together be disposed ina flow control disposition relative to a roller pump assembly. Theroller pump assembly may be concentric with and/or disposed on/in therotor and is adapted to engage one or more tubing lines of one or moretubing and bag sets as these may be disposed on/in the rotor. One ormore totally closed systems may thus be provided hereby. Also providedare simple sterilization and disposability of the fluid container/tubingcombination(s) as well as simple loopless and rotating sealless rotorsfor composite fluid (e.g., whole blood) separation.

Each rotor has one or more buckets or like fluid receiving/containingareas and at least one corresponding fluid roller pump head and raceassociated therewith. Provision is also made for fluid flow from thecontainment area to and through the pump head/race and then back to thesame or a discrete fluid containment/receiving area. Such provision maybe made by a flow channel and/or a tubing line, the tubing line beingeither discrete from or part of a closed fluid container and tubing set.In one embodiment, a composite fluid to be separated into componentparts may then be delivered to the fluid receiving or containment areain a composite fluid container or bag. Then, when subjected tocentrifugal forces, the composite fluid may be separated into respectivecomponents while residing in the respective initial fluid containmentarea. These components may be halted from leaving the containment areaby action of a flow blocking mechanism or clamp or by occlusion by aroller pump head against the tubing line, the roller pump head remainingmotionless relative to the tubing line and thus maintaining theocclusion of the tubing line. Then, once the components (e.g., plasmaand red blood cells or other components, inter alia) of the compositefluid have been appropriately and/or desirably separated, a firstone(usually the lighter) of these components may be pumped while thecentrifuge continues to rotate so as to travel through respectivechannel tubing lines to the respective component collection areas wherethey may be collected in respective collection containers or bags. Eachsuch collection container may be disposed in the same initial fluidcontainment area or a discrete receiving area on or as connected to therotor. A clamping closure of the tubing line may then be effected andthe centrifuge stopped. These separated fluids may then be removed fromthe separation device in or from the container(s), or deformable bag(s).After removal from the centrifuge, they may be stored, furtherprocessed, or may be transfused into a patient. The composite fluid inthis process may be whole blood, and the respective components may thenbe plasma and red blood cells (RBCs), although buffy coats and/orplatelets, inter alia, may also be harvested herewith. Alternatively,the composite fluid can be previously collected blood or bloodcomponents for further separation. Other blood processing operations,such as component washing, or the addition of plasma may also beperformed herewith. Also, RBC deglycerolization or pathogen reduction oragent removal may be performed.

For a composite fluid such as whole blood, where the respectivedensities of the separable component parts, e.g., plasma and RBCs, areknown (within sufficiently controllable ranges), then appropriatecollection containers or bags and pumping systems can be chosen. Afterseparating, the interface is held substantially in position by thecentrifugal field as the plasma is pumped during the pumping/flowprocess. As the bag or container collapses from the top down theinterface substantially remains in position. An optical sensor may beestablished at or adjacent to one or more tubing lines such that as soonas a discrete colored or varied substance (e.g., RBCs relative toplasma) reaches the optical sensor by flowing to tubing after plasmacollection the sensor can signal the need to stop flow. The signal canprovide for effecting a clamping of the tubing line on the suction sideof the pump to avoid overpressure of the tubing and to conclude theseparation. Similarly, if another type of monitor is used, this monitorcan signal for any desired clamping or automatically stop flow. Thispumping relationship governs a general forcing of the fluid flow in onedirection out of the initial receiving/containment area, into theseparation channel/tubing line and from there into the respectivecomponent collection areas which again could be the same as the initialcontainment areas.

The instant invention has the advantage that although the plasma amountof the starting product or composite fluid may vary, the properseparation can be achieved. That is, the completion of the process isdetermined by the identification of a discrete colored substance, forexample RBCs, or the heavier or more dense substance reaching thesensor.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary, and are intendedmerely to provide limited explanation of preferred embodiments of theinvention as more broadly claimed. These and further aspects of thepresent invention will become clearer from the detailed description readin concert with the drawings in which like component elements arereferenced therein with like component numbers throughout the severalviews.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a plan schematic view of a rotor according to the presentinvention;

FIG. 2 is a schematic view of a centrifuge according to the presentinvention;

FIG. 3 is a view of a first embodiment of a tubing and bag systemaccording to the present invention;

FIG. 4 is a portional plan view of a rotor with tubing according to thepresent invention;

FIG. 5 is a plan view of a rotor such as that shown in FIG. 1 includingtherein a tubing and bag system like that shown in FIG. 3;

FIG. 6 is a plan view of the rotor of FIG. 5 after separation;

FIG. 7 is a plan view of the rotor of FIG. 5 during pumping;

FIG. 8 is a plan view of the rotor of FIG. 5 with clamping;

FIG. 9 is a plan view of a rotor such as those shown in FIGS. 5–8 withan alternative bag and tubing set;

FIG. 10 is a view of a first alternative bag and tubing set such as thatshown in FIG. 9;

FIG. 11 is a plan view of an alternative rotor disposition and/or useaccording to the present invention;

FIG. 12 is a plan view of another tubing and bag system alternativeaccording to the present invention; and,

FIG. 13 is a portional plan view of an alternative rotor dispositionand/or use according to the present invention;

FIG. 14 is a plan view of a rotor alternative to accommodate fourbuckets in accordance with the instant invention;

FIG. 15 is a partial cross-sectional view showing a generator mounted onthe rotor; and

FIG. 16 represents an electric circuit attached to the generator of FIG.15.

DESCRIPTION OF A DETAILED EMBODIMENT

FIGS. 1–16 are used to describe the embodiments below. Such figures andthe elements thereof are representational only and are not necessarilyto scale.

A fluid separation system according to the present invention is depictedin the attached drawings and identified by the general reference number10 therein. Note, the processing of whole blood as the composite fluidis described in the embodiments herein, although other composite fluidswith or without certain blood components may also be processed hereby.Red blood cells (RBCs) and plasma are the primary components describedas separated from whole blood herein, although processing for theseparation and collection of buffy coats, platelets or white bloodcells, inter alia, may also be accomplished herewith. Blood componentprocessing such as in washing, adding plasma, or removing additivematerials may also be performed as described here. RBC deglycerolizationor the removal of a pathogen reduction agent from an RBC or plateletcomponent product may also be accomplished herewith as described below.With a few sequence modifications, the primary process generally is alsoapplicable to facilitate wash and/or removal from a blood component ofany supernatant such as a pathogen reduction agent solution (e.g.,photosensitizers such as psoralens, methylene blue, and/or the like)from RBCs or other components (e.g., platelets) undergoing a pathogenreduction process. This could occur in substantially the same fashion asremoving the plasma from the other component(s). RBC, plasma, and/orplatelet collections from whole blood may provide a further optionwhich, in one embodiment, could provide customers with all threeproducts following a single spin of whole blood, packed RBCs in one bag,pelletized platelets or buffy coat platelets in a second bag, and plasmain a third bag. An example of sequencing to yield the three productsfollowing a single spin will be set forth below.

As shown in a first embodiment, for example in FIG. 1, a separationsystem 10 may generally include a rotor 12 (shown schematically) with apump arrangement 14. These may be used in a possibly unique or perhapseven in a conventional centrifuge 13 (see FIG. 2). Although generally ina conventional centrifuge the buckets or containment areas pivot duringcentrifugation, such a feature is not necessary with respect to thepresent invention. That is, the buckets or containment areas can befixedly mounted on the rotor. The rotor 12 may also include one or morecontainment areas or buckets 15 (six shown). A bag and tubing system 16,see FIG. 3, may be used herewith as shown for example in FIGS. 5–8 whereeach such tubing set 16 has one or more respective tubing line(s), onlyone such respective line 18 being shown in FIGS. 4–8 (access needletubing line 17 (FIG. 3) having been removed), and associated reservoirsor bags 20, 22. As introduced, a tubing set 16 with associated tubingline(s) or conduit(s) or transport channels 18, and bags 20, 22 is shownin more detail in FIG. 3 and is further described below. These primarycomponent parts and some optional tubing lines and associated optionalcomponentry will also be further described below. Note, the option ofusing an anticoagulant (A/C) , though such anticoagulant may and oftenwill be pre-packaged (not directly shown) in the whole blood collectionbag 20, and/or may be later added (after disconnection from the donor).

It is understood that other features found in disposable tubing sets canbe used with the principles of the current invention. For example,filters for leukoreduction or other purposes and/or containers includingstorage solution or other additive solutions may be included in thedesired disposable.

FIGS. 1 and 5–8 show a six bucket centrifuge rotor 12 with a roller pumpmechanism 14 located concentrically with the centrifuge rotor 12. Thepump heads 141 are free to rotate relative to the rotor 12 around axis45. The race 142 is fixed to the rotor 12 and must therefore rotate atthe same rate as the rotor 12. Whole blood bags 20 and plasma bags 22are placed into the buckets 15 as shown in FIGS. 5–8. The tubing lines18 connecting the two bags 20, 22 of the respective sets 16 (see FIG. 3)are loaded into a channel including the roller pump raceways 142 (seeFIG. 4). Note, all or part of tubing lines 18 may be of sufficientstrength and/or thickness to be adapted to operate in a pump raceway, oralternatively a tubing header portion (possibly thicker or of slightlydifferent material) may be appropriately formed or otherwise disposed intubing line 18 in adaptation for operable engagement with the pump 14.FIG. 4 also shows an enlarged depiction of one possible embodiment of araceway system engagement with one tubing segments 18. The raceway walls142 against which the heads 141 roll and compress respective tubings 18are shown. Additional slots 143 are also shown for accommodating tubings18 in this embodiment. As shown there is at least one conduit engaginghead 141 associated at any one time with each piece of tubing 18 so thatthe tubing may be occluded. The number of conduit engagement heads 141in the pump assembly 14 can be varied and are selected so that there isat least one head 141 associated at any one time with each tubing 18.

FIG. 5 shows the centrifuge as loaded and prior to actual separation ofcomponents with whole blood in bags or containers 20 inside thecontainer area or buckets 15. FIG. 6 shows the rotor 12 spinning at highRPM in the counter clockwise direction. Due to friction between eachpump head 141 and each tubing line 18 loaded in each race 142, the pumphead 141 will rotate with and at the same RPM as the race/rotorcombination and therefore fluids will not be pumped. At this high RPM,RBCs 92 and plasma 91 will separate in each respective bag 20. FIG. 7shows a subsequent period after that shown in FIG. 6 with the rotor 12reduced to a low RPM maintaining rotation of the rotor 12 and the race142. A mechanism 201 (not shown in FIG. 7 but see FIG. 15) is used tostop rotation of the pump head assembly 14 resulting in relative motionbetween the still rotating rotor 12 and pump race 142 and the pump headassembly 14. Alternatively, the relative motion between the pumpassembly 14 and the pump race 142 can be achieved by varying the speedor RPMs of one of the pump assembly 14 or the pump race 142 as comparedto the other. Also, the rotor 12 and pump race 142 can be stopped whilethe pump assembly 14 is rotated. Again the only limiting feature is thatthere be relative movement between the pump assembly 14 and the pumprace 142 to produce the pumping motion. This relative motion results ina pumping action with plasma being pumped into the plasma bag 22.

Optical or other sensors 99 (not shown in FIGS. 5 and 6, see below andFIG. 8) may be used to sense the presence of RBCs 92 in each tube 18 andtrigger clamps 19 for each bag preventing the transfer of red bloodcells 92 to plasma bag 22. This also permits variable volumes of plasma91 to be pumped into each bag 22. FIG. 8 depicts each tubing 18 clampedon the suction side of the pump head 141, thus preventing overpressureof each tubing 18 as rotation of the rotor continues.

FIGS. 9 and 10 show an alternative bag set 160 (FIG. 10) having anadditional container or bag 26 in the tubing line 18 to collect plateletcontaining buffy coats. Again, clamp sensors 199 can be used to monitorthe passage of components wherein red blood cells in general remain inbag 20, buffy coats in bag 26 and plasma moves to bag 22. FIG. 10 showsbag set 160 apart from the rotor 12. If bag 26 is placed into a rigid,constant volume chamber or container on/in rotor 12, (see FIG. 9) allbuffy coat collections will contain the same volume of buffy coatproduct. As noted above, the use of rigid containers is a possiblealternative for all bags.

As shown in FIG. 1 and also in FIGS. 5–8, a rotor 12 may have six (ormore or less) general containment areas or buckets 15 (also sometimesreferred to as pockets herein). These areas 15 may be where thecomposite fluid (e.g., whole blood) is received and initially contained,then also where the separation is accomplished. Thus, these areas may bereferred to as containment and/or separation and/orcontainment/separation areas. These same areas 15 may also be where RBCsare retained and/or collected in a storage container which may bediscrete from or identically the same as bag 20 and may also include aplasma collection area or bag 22 for collection of plasma. These bucketsor areas 15 may include all of these sub-areas with or withoutspecifically bounded means 183, i.e., walls or partitions (not shown inFIG. 1, but see FIG. 11) inside the buckets or areas 15 to subdivideeach bucket or area 15 into respective separated component sub-areas184, 185, e.g., an RBC sub-area and a plasma sub-area (see FIG. 11).Such partitions or walls may optionally be moveable in some fashion toallow for re-distribution of separated material from a configurationsuch as that shown in FIGS. 3–5 (where all materials, separated orotherwise) reside in a single container 20, to the configuration shownin FIG. 8 where a certain quantity of separated materials have beenmoved from the first container 20 to the second container 22. As shownin FIG. 8 this resulting relationship is side-by-side. However, therelationship could instead be one on top of the other, or otherwisedistributed, particularly if physical boundary members (e.g., walls orpartitions) are used. Also, optionally, the plasma container or bagcould be a closer radial distance than the whole blood or othercontainer bags although this is optional and not necessary.

As depicted in FIG. 6, the separation is effected by rotation in thecounterclockwise direction at high RPMs in an overall fluid flowconfiguration presented by rotor 12 and pump assembly 14 which rotatetogether to provide a no-flow situation at high RPMs. At a lower RPMforward flow control is provided by the heads 141, see FIG. 7. Then, therotor configuration which includes a substantially central compositefluid pumping arrangement 14 which acts on transport channels or tubing18 may be activated optionally at low RPMs by disengagement from therotor (see element 201, FIG. 15) after separation completion. Atransport channel may be discrete from or may solely include tubing 18,but provides for fluid communication from bag/container 20 tobag/container 22. Activation of the pumping action of the pump headassembly 14 at low RPMs may include a relative stoppage of pump headassembly 14 to zero (0) RPMs while the remainder of the rotor 12continues to rotate at low RPMs or, alternatively, a relative change ofspeed can be used as described. When the pump head assembly is stoppedthe races 142 will continue to move relative to the stopped heads 141which will then cause a peristaltic pumping action of fluid in tubinglines 18 from each bag 20 to each bag 22. The lighter phase componentfluid which floats on top of the more dense phase will be first movedout of the bags 20 (see flow arrows 30 in FIG. 7). Pumping in thisfashion may continue until the desired amount of component has beenremoved (see FIG. 8). As shown in FIG. 8 pumping of the lighter phasecomponent 91 results in collapse of bag 20 from the top down leaving arelatively stable and stationary interface.

The above refers to separation by rotation in the counterclockwisedirection followed by stoppage or changing speed of the pump assembly orpump race to produce relative movement between the pump assembly 41 andthe pump race 142. It is understood, however, that the relative movementcan be achieved in other ways as described above. It is furtherunderstood that the only limit on the direction of rotation for pumping(which could be in the clockwise direction), is that flow of the lightphase component be toward the collection bag.

Visual monitoring by a human operator may be used to determine when flowshould be halted; specifically, when substantially all (or a desiredquantity) of the separated lighter phase component (e.g., plasma) isremoved from bag 20 and moved to bag 22. Otherwise, a timing mechanismcould be used to halt pumping or one or more optical sensors 99 (FIG. 8)or other sensors or level detectors as more fully described below couldbe used to sense when the heavier phase component (e.g. RBCs) beginleaving the bag 20, thus indicating when the lighter phase component hassubstantially been removed. Clamps 19 (shown schematically) or otherflow stoppage members could then be activated on lines 18 (independentlyor simultaneously) when flow stoppage is desired (whether from visual,timing or optical or other types of sensing or detecting). Magneticapparatus (not shown) to stop the relative movement between pump headassembly 14 and rotor 12 may be a means for this purpose. However, discbraking or other stopping means may also be available.

Other types of sensors and/or clamps or flow stopping devices could beused to prevent a heavier phase component from leaving bag 20. One suchflow stopping device includes the use in the bag 20 of a ball ofmaterial of suitable density to float between the lighter phase and theheavier phase. Such a ball can effectively act as a plug for the bag 20at the port leading to tubing 18, closing the entrance to tubing 18 whenthe red blood cells start to exit the bag.

Note, the rotor 12 shown in FIGS. 1 and 4–8 may be formed by variousmethods using a variety of materials. However, formed metals and/ormolded plastics may also be used, as may other lightweight yet verydurable parts. Simply designed pockets or containers 15 may then beeasily constructed and disposed in rotor 12. The rotor 12 may bereusable with disposable bag and tubing sets, however the rotor 12 mayalso be made for disposability (as for example, if the rotor 12 may beused for blood separation without a bag set 16, e.g., formed channelsand a fluid tight lid (not shown) may be disposed in/on rotor 12 whichcould thus be used for such a purpose). In either case, numerousrepetitive uses with a series of discrete bag or container sets 16 maybe used; such bag or container sets provide for the complete scaledenclosure of the blood and blood components therewithin so that therotor 12 does not come into contact therewith. Rotor 12 would thenrequire limited or no sterilization or disposal after each use.

An alternative rotor 112 having four containment areas or buckets 115 isshown in FIG. 14. This rotor 112 also has a substantially centralcomposite pumping arrangement or assembly 114 with pump race 242 andaxis 145. Pump heads 241 are arranged so that at any one time at leastone pump head is adjacent tubing 18 (tubing not shown) of each bag set.Clamps or valves similar to 19 and sensors could also be used with thisembodiment. It is understood that the number of containment areas orbuckets can be varied to process the requisite number of collections andthat four or six containment areas are just exemplary.

As introduced in FIG. 1 above system 10 uses a tubing and bag system 16which is shown in more detail in FIG. 3. As shown here, this bag system16 includes two bags 20 and 22 each connected to each other throughrespective tubing lines 18. An initial collection line needle assembly17 is also shown, although this may be removed by RF sealing and cuttingat or near point 17 a. After separation and transfer of plasma to bag22, the plasma bag 22 may be sealed off from and cut and/or removed frombag 20 using, in one example, a radio frequency (RF) heat sealing device(not shown) as understood. This removal may be made at a portion oftubing line 18 near bag 22. The remainder of tubing 18 may also beremoved from bag 20 as well. As will be described, if more than two bagsare used, similar disconnections of such bags (not shown) and/or attheir respective tubing lines may occur, though occurring after thecentrifugal separation process.

In one possible embodiment, wherein a rigid container is used instead ofbags 20, 22, such rigid container could also include an air ventstructure (not shown) to either allow air to enter the container asseparated phases of fluid are removed or allow air to leave thecontainer. Microbiological filters (0.2 micron size and the like) may beused in or with vents (not shown) to maintain sterility. Each of thebags or containers may also include a port structure 25 (see bags 20 and22 in FIG. 3) for, inter alia, subsequent access to the collectedseparated components which may be disposed therein. Other structuresand/or uses therefor may be disposed on or in or for each bag orcontainer as may be understood and/or desired in the art.

Note, construction of the bag and tubing line parts of system 16 maytake many understood forms and use many known materials, includingflexible materials. For example, RF or heat welded sheet plastic (e.g.plasticized PVC bags and extruded flexible tubing lines can be used, asmay blow-molded or other types of containers (e.g., glass, plastics) andlines. Even vessel 26 (see FIGS. 9–10, described below) may be formedfrom RF or heat welded flexible plastic sheets or may be blow-molded orotherwise formed as a rigid container and thus in a non-flexible form.

Returning now to FIGS. 1 and 2 and including further reference to FIGS.5–8 a general description of the blood and blood component flow paths,when device 10 is used for the separation of blood into components, willnow be described. First, note that the flow paths are within bag andtubing set 16 as disposed within rotor 12 (see FIGS. 5–8); however, insome embodiments, a bag set may not be used and the respective flows maysimply be in sealed channels and pockets of rotor 12 (thus, channels maybe formed in a rotor part and correspond to tubings such as tubings 18,whereas the pockets would correspond to the buckets or areas 15). In anycase, as generally shown, particularly in FIGS. 1 and 2, for the tubingline or channel flow paths, whole blood is collected from the donor vialine 17 and disposed in the bag 20 (as is generally known in the art)perhaps while bag 20 is in, but before disposition of bag 20 in thecentrifuge device 10. If before disposition in rotor 12, then bag 20 maybe disposed in a separate container (not shown) or hung from a hook orplaced on a scale (not shown) as understood in the art for collection ofwhole blood from a donor, or in a fashion which allows for gravitydrainage thereinto. A temporary outflow stopper as by a frangibleconnection or a slide or roller clamp (not shown) may be used in line 18during collection in bag 20. Shown in FIG. 3 are the other tubing linesof tubing system 16 which provide the inlet and exit flows to and fromthe bag 20 as this will be disposed in the centrifuge rotor 12 duringsubsequent centrifugation. Thus, during such centrifugation (and afterdisconnection from a donor) the whole blood will be restricted or notallowed to flow from bag 20 to the bag 22 through tubing line 18.However, after separation in bag 20, the separated blood components; inparticular red blood cells (RBCs) and plasma, will be separated suchthat the plasma will flow through respective tubing lines 18 forcollection in respective containers 22. The RBCs will remain incontainer 20 and plasma flowed through tubing line 18 for collection incontainer 22.

Note, shown schematically also in FIG. 8 are optional clamps or valves19 disposed in or adjacent channels or tubing lines 18 and which may beused to ensure no flow conditions in channels or tubing lines untildesired, as for example, until a sufficient rotational speed has beenachieved. Heads 141 of assembly 14 may be used to occlude lines 18 untilflow is desired. Optical sensors 99 are also shown schematically asthese may be disposed in/on or relative to rotor 12 and tubings 18.Sensors 99 would sense when a different phase (darker vs. lighter, e.g.)would reach into tubing 18 and would provide a signal (using logiccircuitry and/or a computer chip) which would be used (interpreted orthe like) to or for closing the associated clamp valve 19. Other typesof sensors or flow restrictors could also be used as described above.

Prior to and during centrifugation, the tubing lines 18 are disposed incorresponding channels particularly, at least races 142 formed in/on therotor 12. Thus, the flows in and through the centrifuge unit 10 are asfollows (with or without tubing lines, as introduced above). Whole bloodfrom the donor now contained in bag 20 (or perhaps collected otherwise,e.g., directly into rotor 12 into a containment area/bucket without abag 20) is initially placed in the composite fluid containment area orbuckets 15 of the rotor 12. The empty plasma bags 22 are positioned intheir respective collection buckets 15 as are the respective tubinglines 18 within their respective channels or races 142. While in thereceiving/containment area or buckets 15, the blood is then exposed tocentrifugal forces when rotor 12 is spinning (which the rotor 12 is madeto do after the whole blood, in bag 20 is placed into or is otherwiseresident within centrifuge unit 10). Note, the initial exposure of bloodto the centrifugal forces is relative to the axis of rotation 45 (seeFIG. 1 where axis 45 is shown as a central point indicating theperpendicularity thereof relative to the drawing sheet). Under thecentrifugal forces of the spinning rotor 12, the blood and particularlythe heavier phase component 92 (RBCs) thereof is moved to the peripheryof the containment area 15 (see FIG. 6) and is thus generally moved intoa generally abutting relationship with the bottom wall which defines thecontainment area 15.

After the separation, the cooperative rotation of pump assembly 14 withrotor 12 is stopped or varied so that rotor 12 can continue to rotate ata different RPM than the pump assembly. A continuous flow of a separatedblood component, e.g., plasma, 91 will then be made to flow from thefluid receiving area 15 into the channel/tubing line 18. This bloodcomponent will then travel substantially inwardly radially to the pumphead. This is shown schematically in FIG. 7 wherein flow arrows areprovided to show the direction of flow throughout the centrifugationconfiguration therein. This first flow is indicated by flow arrow 30(See FIG. 7) continuing from the bag 20 to the pump assembly 14 and thengoes radially outwardly back to the containment/receiving area 15.First, it should be noted that when the centrifuge rotor 12 is spinning(again, as it will be whenever blood is disposed therein), this willimpart centrifugal forces on the blood which will then separate it intotwo primary components; namely, red blood cells (RBCs) and plasma. Theheavier RBCs will settle outwardly under these centrifugal forces, andwill thus accumulate, against or adjacent the outer wall of containmentarea 15. This action is shown in detail in FIG. 6. The plasma isidentified generally by the reference number 91 in FIGS. 6–8, and theRBCs are similarly identified generally by the reference number 92.Whole blood prior to separation is shown in FIG. 5 and identified by thenumeral 90 therein.

At least one optical sensor working in combination with at least onevalve 19 (see FIG. 8) retains the more dense phase within containmentarea 20. This yields a distinct advantage. First, after separation andthus formation of an interface (see FIGS. 6 and 7) the plasma is removedfrom the bag 20 by the pumping action of assembly 14. During thispumping step the plasma is removed from the top of the bag and the bagcollapses downward with the removal of plasma volume.

Various methods can be used to control the collapse of the bag so thatthe bag does not fold on itself and thus allowing the interface toremain relatively stable and stationary. Also controlled collapse willprevent the more dense phase or RBCs from being trapped in crevices orfolds of the bag and help prevent less than optimum separation. Theseinclude, but are not limited to, tenting or hanging the bag. It is alsounderstood that other methods for retaining the shape of the bag forproper collapse can be used.

The interface should be controlled in bag 20, so that it remains eitherradially outwardly enough so that the separated plasma can be movedthrough the outlet channel (the post-pump portion of tubing 18) and intobag 22 without undesirably diluting the plasma product with buffy coator the RBC product. The “buffy coat” blood component, as known in theart, generally rides on the interface. The buffy coat generally includesplatelets and white blood cells therein. The interface remainscontrolled because the centrifugal field is maintained during pumping.

An alternative could involve capture of these buffy coat bloodcomponents which could prevent contamination of either of the RBC orparticularly the plasma products as well as potentially being useful infurther processing to capture platelets separated from buffy coat cells.White blood cells (WBCs) which are substantially captured by the buffycoat are particularly unwanted in RBC, plasma and platelet products.However, because centrifugal separation will less effectively separateWBCs from RBCs (or platelets), the WBCs are more likely to be addressedseparately relative to the RBCs (or platelets) with a (pre- or)post-centrifugal processing and/or filtration. In other words, thepresent invention, like other centrifugal separation systems, willlikely not sufficiently leukoreduce red blood cells. Rather, althoughthe buffy coat including the WBCs will ride on the RBC layer, they willnot likely be sufficiently separated from the RBCs here so as to producea leukoreduced RBC product. However, the buffy coat including WBCs canbe sufficiently centrifugally separated from the plasma product by thepresent invention so long as the interface is sufficiently controlled astaught herein.

Note, the buffy coat may be retained sufficiently in an optional vessel26 (FIGS. 9 and 10) (particularly using the automatic opticallysensed/activated shutoff feature) so that the buffy coat may becollected and further processed into component parts (such as platelets,e.g.) for farther use in transfusion, inter alia. Thus, as with theprevious embodiment of FIGS. 3–6, an optical sensor 199 appropriatelypositioned adjacent to the container 26, would sense when a distinctlycolored substance (e.g., the buffy coat and/or RBCs) arrives at thatpoint, at which time this sensed parameter can be used to signal forclosure of a clamp, see, e.g., clamp 119, FIG. 9) to stop flow in thetubing line 18 and thereby capturing buffy coat in vessel 26, which alsocaptures RBCs in bag 20 and plasma in bag 22.

One primary advantage of a system such as this is that the lighter phasecomponent plasma 91 can be made to continuously flow from the collectionarea 15 while the blood components are still in the centrifugal forcefield, and blood components 91 and 92 thus remain continuously separatedand/or remain continuously separating therein even during thiscontinuous flow out of the bags 20 and into the respective collectionareas or bags 22 of rotor 12.

Several other important advantages are achieved with a system such asthat shown and described herein. A first such advantage is theelimination of numerous complex control elements which were oftenrequired in previous centrifugal separation systems. For example, theseparate manual expresser required for traditional bucket separationprocess can be eliminated. Furthermore, no separate expressor fluidsystem is necessary. Also, the optical/valve interface control shown anddescribed here eliminates the need for other feedback loop interfacecontrol elements including complex pump controls, for example. Thepresent controls can also be substantially independent of the bloodhematocrit (within normal ranges of donor hematocrit) and relative flowrates of the inlet and outlet fluids. This eliminates the need forcomplex flow rate calculations and pumps and pump controls therefor(i.e., eliminates computer calculations and multiple flow control pumps;in various conventional embodiments, multiple pumps, inlet and outlet,have been required to be maintained in dynamic control relationship witheach other constantly by computer in order to provide proper interfacecontrol). Thus, at the least, no inflow pump is required here, and aseparated blood component may instead be fed from the whole bloodcontainer 20 into the tubing line 18, and through optional vessel 26 bythe cooperating forces of the spinning rotor 12 and the relativelystationary fluid roller pump 14. The lack of an inflow pump and closed,but batchwise/continuous process as well as the less complex rotationaldrive mechanism further eliminates the need for a rotating tubing loop.This serves to greatly reduce the quantities and sizes of the mechanicalcomponents (tubing loops in rotating loop systems often generallydictate the minimum mechanical element requirements and size). A closedbatchwise system (no inflow pump) also eliminates any need for arotating seal at the inlet connection of the inflow line to theseparation device. This greatly reduces complexity and a large potentialfor operational failure. Also, the rotor and housing combination areeasily made in a totally closed system which can be simply sterilizedand can be completely disposable, or, as particularly in the case ofrotor 12, reusable without sterilization particularly if used withcompletely closed, sterilized tubing bag systems 16 as described herein.The reduced mechanical and control complexities contribute to thedisposability and/or reusability benefits as well.

One advantage of the instant invention is that more plasma can becollected or separated than by the traditional manual expression of theblood bag using a separate expresser apparatus after centrifugation.This allows more plasma to be available for various needs and allows theresidue cell component to have less plasma.

A further advantage can be realized in the output product quality.Particularly, due to the suction action of the pump and bag collapse inthe current invention the interface may be stable and non-moving duringpumping and thus virtually all of the plasma is removed. Removal of theplasma under the g-forces of the centrifugal field helps maintain thestable interface. Also, a virtually constant maximum hematocrit may beobtained for all resultant red blood cell products because the presentlydescribed separation device may be operated within a range ofrevolutions per minute (RPMs) at which the product hematocrit does notsubstantially vary. For example, the present invention may be operatedat high RPMs; speeds which are heretofore not usually achievable forvarious reasons (e.g., drive mechanism or tubing loop or rotating sealproblems at such high speeds). And, at such speeds, virtually all RBCswill be separated out from the input whole blood, thus yielding an RBCproduct with the highest available hematocrit. Note, the highestavailable hematocrit is a number above 80% and less than 100% and whichapproaches a substantially constant asymptote which is in the area ofapproximately 90 or 95%. At speeds in the range of such high RPMs, theresulting hematocrit is virtually equivalent to the asymptotic maximumthroughout that range. At much lower speeds (e.g., 3000 RPMs or below),the resulting hematocrit may significantly diverge from the asymptoticmaximum. FIG. 8 shows the system at or near the end of a process suchthat the original whole blood bag 20 and the collection bag 22 arefilled with respective high quality RBC and plasma products. In the FIG.9 embodiment the same high quality is also achievable with littleremaining in the vessel 26 except a desirable buffy coat product. Note,an appropriately sized chamber (not directly shown) to hold vessel 26could assist in capturing only the buffy coat in a flexible vessel 26and at a constant predetermined volume. Or, as a similar alternative,vessel 26 could be a non-flexible member of a particular pre-selectedsize and shape which could be used to maximize the buffy coatcollection/retention therein and minimize the inappropriate dilutionthereof with either plasma or RBCs.

Note, a further primary advantage is that a rotor 12 configuration withbuckets 15 can be made in unique centrifuge machines, or can beretrofitted onto/into pre-existing currently available centrifugemachines, such as those commonly manufactured and distributed byHitachi, Ltd. (Japan) or the Sorvall Corporation, a.k.a., SorvallProducts, L. P. (Newtown, Conn.) (see e.g., FIG. 2). Pump assembly 14braking members (not shown) may also be retrofitted onto suchpre-existing, currently available centrifuges as well.

Referring once again to FIG. 1, a few basic alternatives will now beaddressed. First, it should be noted that the embodiments shown in FIGS.1–8 may also provide for separation of other composite fluids capable ofcentrifugal separation. Indeed, other blood component products may beprocessed using this system. Thus, where the FIGS. 1–8 embodiment isgenerally directed to separating composite fluid in a container 20 intotwo primary components and then moving the lighter phase into the othercontainer 22; this can be used for processing, e.g., washingglycerolized RBC products, or for removing pathogen reductionagents/solutions from blood components such as RBCs and/or platelets.

More specifically, in a pathogen reduction process, this two-bag systemcould be used first to separate whole blood into component products asdescribed above; after which separate processes and/or machines could beused to add and/or activate (e.g., illuminate) pathogen reductionagents/solutions (e.g., photosensitizer solutions) to the separatedblood component products. Then, the systems of the present inventioncould be used again to centrifugally separate the pathogen reductionagents/solutions from the now-processed blood component product (RBCs orplatelets). The RBCs or platelets would be a heavier phase product whichwould remain in the initial bag 20 while the lighter phase pathogenreduction agent/solution would be lighter and after centrifugalseparation could then be pumped out of the initial bag 20 by pumpassembly 14 into a secondary bag 22 via a tubing line 18.

Another basic alternative available with this invention involves theoptional return of certain separated blood components back to the donor,rather than retaining these in the collection reservoirs 20, 22. Anexample embodiment for returning a quantity of either (or both)separated RBCs and/or separated plasma back to the donor is not shown inthe drawings but may take place after centrifugation, collection and anyfurther processing is completed. As such, a bag 20 containing separatedRBCs and/or a bag 22 containing plasma may be removed from the rotor 12and then treated, stored or otherwise dealt with in the ordinary course.Then, when reinfusion to the donor or transfusion to a patient isdesired, an infusion line (not shown) may be connected to and through aport structure 25 in a fashion known in the art (using, e.g. a spike,needle or other sterile docking connection means). Then, when it may bedesired to return a quantity of a separated component (RBCs or plasma)to the donor (or transfused to another patient), the desired componentmay then be allowed to flow out of its respective container 20 or 22 orthe like, through its respective return/infusion line (not shown), backtoward and into the donor or patient. Accomplishment of these particularflows may simply involve gravity drainage of the desired blood componentfrom its collection/storage bag 20 or 22, and/or it may involve the useof one or more pumps which may be of the peristaltic type. Thus,respective pumps may be engaged with each return/infusion line (notshown) and then may be activated at a desired operational point to pumpthe desired separated blood component out of its reservoir and throughthe respective tubings, and back into the donor or patient.

Another alternative to the present invention is related to the pumpingaction. Although the rotation of the pump is stopped for relativemovement between the rotor 12 and pump heads 141, it is understood thatpumping could also be achieved after the rotor 12 ends its rotations.That is, the pump assembly 14 could be the rotating element duringpumping.

One requisite for pumping is that there be relative movement between thepump race on the rotor and the pump head assembly. As described above,this can be achieved by altering the rotational speed of either the pumphead assembly or pump race. For example, one of the pump heads or rotorscould rotate at a different RPM than the other. Alternatively, acomplete stoppage of one could be affected as described above.

Although a single containment area is described in the previousembodiments it is understood the containment areas could be partitionedby a wall such as 181 as shown in FIG. 11. Such a wall could also beused without a disposable where the fluid is moved through closedchannels from one containment area to the other.

Another alternative using a centrally disposed pump assembly is analternative where a ring-like separation bag is used. The pump assemblyhead could be used to pump through tubing connecting the ring-likeseparation bag to secondary bags. Also, it is contemplated that theroller head assembly can contact the separation bag itself. Thus thefeatures of the instant invention can be applied to a number ofdisposables, not just the one described above.

Another alternative using the two bag systems 16 shown and describedabove (or other systems, see below) could be used to achieve plateletproducts and could be run as follows. First, after loading one or morewhole blood products in respective bags 20 into respective buckets 15,the rotor 12 could be spun in a “soft spin”; not too high an RPM so that(as is known in the art), the whole blood in bags 20 can be separatedinto RBCs and a platelet rich plasma (PRP) product. Then, the rotor 12can be slowed to an appropriate speed (RPMs) and the pump head 14stopped or slowed to pump the platelet rich plasma to the second bag 22.Then, a hard spin can be made and platelets settled to the bottom of thesecond bag 22, and the RBCs packed tighter (higher hematocrit) in thefirst bag 20. Plasma thus further separated from the RBCs in bag 20 canbe further transferred, if desired, to bag 22 to provide a higherhematocrit final RBC product in bag 20; and, the plasma in bag 22 can beremoved therefrom using a conventional expresser or an expresser similarto 181 moveable about pivot 182 in bucket 15 (FIG. 13) into a third bag23 (see FIGS. 12 and 13) through a line 18 a. This third bag may besubsequently added to the two-bag set 16 or may be integral therewith(see FIGS. 12 and 13). As introduced above, this subsequent expressioncan be made to take place inside a bucket 15 (see FIG. 13) or outside,after careful removal and placement on a conventional expresser. Afurther alternative to the above two bag method to remove plasma fromthe PRP is that the rotation of the centrifuge or rotor 14 can bereversed to remove the plasma from bag 22 rather than using an off-lineexpressor.

Such a process provides several advantages. First, over conventionalsystems in which a PRP product is made in a standard bucket centrifuge,the separated PRP and RBC product must be removed from the bag byremoving the bag from the centrifuge very carefully and placing this bagin a conventional expresser to remove the PRP from the separated productbag. Then, the expressed PRP product must be re-packed into a bucket,re-centrifuged, and then re-expressed. This process, that second spinand intermediate external expression with the inherent manual handlingrequired thereby are avoided by the current invention. Both manual andmultiple machine steps are avoided hereby. Note, manual handling in theconventional methods creates a significant amount of interfacedisruption and mixing of the centrifugally separated component products;this re-mixing being avoided with the present system. Also, and again, ahigher crit (hematocrit) RBC product would also be obtained and moreplasma product can be harvested.

Turning now to a few more alternative embodiments, reference is firstmade to the plan view shown in FIG. 13. The primary distinction thiscentrifuge rotor 12 has over that shown, for example, in FIGS. 1–8, isthat the separation buckets 15 have an expresser 181 moveable about 182therein and a three bag set such as that shown in FIG. 12 is disposedtherein. Nonetheless the functionally remains substantially the same inthis embodiment as it was in the embodiment of FIGS. 1–8. A compositefluid is still separated in a primary bag 20, and from there a separatedcomponent is flowed out of the containment area, to each respectiveoutlet or collection area or bags 22.

However, in further operation, this FIG. 13 embodiment works asdescribed before, but is rotated again about a central axis 45 as shownin FIG. 1 for further separation of the component product in bag 22after which the expressor 181 can be engaged to move the lightest phasecomponent, e.g., plasma from bag 22 to bag 23. This expression can bemade to take place during continued rotation of rotor 12, or after rotor12 has been stopped. The movement of the expresser about 1 82 can be toa predetermined stop to provide a predetermined volume in bag 22.

Thus, either platelets or a buffy coat product can be captured insidethe intermediate bag 22. A first soft spin and first movement ofcomponent from bag 20 to bag 22 may yield a PRP product in bag 22followed by a second, harder spin resulting in a pelletized (orotherwise more packed) platelet product in bag 22. However, if the firstspin is a hard spin, then the separation in bag 20 is into a plateletpoor plasma (PPP), a buffy coat and a packed RBC product. In such acase, both the PPP and the buffy coat would need to be moved to thesecond bag. Forward flow is here first also caused and maintained by theengagement of the roller pump 14 as before. Then, a second hard spin canbe used to separate the buffy coat from the PPP in the second bag andthe PPP can be expressed to the third bag, thus capturing the buffy coatin the second bag 22. Note, though not shown, the PPP bag 23 could beconnected by tubing line directly to the first bag 20 with the firstmovement of PPP pumped via roller pump assembly 14 thereto; followed bybuffy coat expression into bag 22 as described.

A further alternative here for buffy coat-like processing takes note ofthe fact that the buffy coat is processed better when it rides on a bedof RBCs. Thus, prior to any centrifugation a small quantity of wholeblood may be moved from the initial container 20 to the intermediatecontainer 22 (e.g., via roller pump 14 and tubing line 18). Thenprocessing can proceed as introduced above. The processor can be first asoft spin then transfer of the PRP from bag 20 to bag 22, then a hardspin where the platelets separate and yet rides on a small layer of RBCsin bag 22, followed by the expression of PPP from bag 22 into bag 23.

The completion portion of the centrifugation process provides forsubstantially (if not completely) all of the whole blood (or likecomponent fluid) to be separated with bags 20 and 23 having beensubstantially filled with respective components, RBCs 91 and plasma 92,with a minute remainder of fluids (or a platelet or a buffy coatproduct) in the intermediate bag 22. Rotation of rotor 12 can then bestopped and bag set 16 removed therefrom. Tubing lines 20, 21 can thenbe heat sealed and/or cut to separate collection bags 20, 22 and 23therefrom for subsequent storage processing and/or use in transfusion(as known in the art). Note, the centrifuge rotor may be equipped withclamps and/or RF welding devices (powered through slip rings) which maybe activated to clamp and/or weld and/or cut the tubing lines inside thecentrifuge to provide isolated product bags prior to removal by theoperator. Note also that preliminary or subsequent processing (e.g.,leukoreduction, filtration, viral reduction or storage solutionaddition) prior to storage or use of the separated components may alsobe desired, and such may be performed before or after completion of thecentrifugation process.

A challenge in implementing the RBC/plasma separation device describedhereinabove involves mechanization of the process. Situations often maydictate a preference for processing of more than one whole blood unit ata time. According to some embodiments of the present invention, theabove rotors are designed to be accommodated on and or by a standardcentrifuge machine such as those which typically accommodate more thanone whole blood unit or bag 20 with its associated component collectionbag(s) 22 (23). Such is provided by the embodiments hereof.

As introduced in the above-described embodiments, the single bloodseparation pathway of the initially described centrifugationconfiguration embodiments (see FIGS. 1–8 and 9–11, e.g.) can be dividedinto multiple, usually opposing flow pathways. For example, FIG. 1 showsthe incorporation of six discrete processing areas 15, in/on one rotor12 while FIG. 14 shows four. As the number of processing areas and/or asthe, increases then larger driving centrifuge motor bases (not shown)will likely need to be used. Nonetheless, it appears that a multi-unitrotor such as rotor 12 of FIGS. 1–8 (or other quantity units from two upto perhaps eight, twelve, or even more units) may be made to replace therotor of an existing bucket or cup centrifuge machine; such machinestypically already being used in blood banks for blood componentseparation. Thus, existing drive machinery may be used to generate theforces desirable for separation and flow (e.g., high revolutions perminute (RPMs) and/or large g forces such as up to perhaps 5000 g's(5000×gravity), for an example). A limiting factor may be the vaporpressure of the fluid as this may be related to the relative head“height” presented by the distance of the fluid away from the center ofrotation. That is, if the distance is too far for the particular fluid(and its characteristic “vapor pressure”), the pump may not be able topump over the vapor pressure of the fluid and a sort of vapor lock,no-flow condition could result. One option for correcting this problemis to use lower RPMs. Another option is to reduce head “height” of thesuction part of tubing 18.

Among various advantages of these embodiments, one may be found in thetubing and bag sets 16 which may be used herewith as shown, e.g., inFIGS. 3 and 12. The tubing and bag sets 16 of FIGS. 3 and 12 differ verylittle from each other. For example, there are two or three primarybags; a composite fluid/whole blood bag 20 and one or two separatedcomponent bags 22 and/or 23 (RBCs collected in bag 20, and plasma in bag22 or 23 and platelets or buffy coat collected in the other secondarybag 23 or 22) with associated tubing line connections 18 and 18 aemanating therefrom. These bags are also made in the same fashion andfrom the same types of materials as the other conventional bags. (Note,as introduced above, a bag was suggested as an alternative vessel 26 forthe embodiment of FIG. 10, as well). Nevertheless, these bags may beshorter (or longer) and/or perhaps wider (or thinner) and/or may haveless (or more) volume than any of the other bags, depending primarily onthe composite fluids to be separated and the relative componentsresulting therefrom, and/or the rotor configurations chosen, e.g., thelength and width of the separation bucket 15 or otherwise as may bedesired. Bottles or containers of other types may also be alternativelyused herein with air vents being included in hard wall containers forproper fluid flow.

FIGS. 15 and 16 illustrate an optional feature to the centrifugeconfiguration described above. FIG. 15 is a partial cross-sectional viewshowing rotor 12 and pump assembly 14 as described above. Element 201represents a brake or other apparatus or mechanism for stopping pumpassembly 14 from rotating with rotor 12, also as described above. Thebrake would be engaged during the pumping mode to stop the rotation ofpump assembly 14. A generator is shown at 202 attached to rotor 12.Although only one generator 202 is shown it is understood that severalcould be mounted on rotor 12. A belt 203 is shown passing through slot207 on rotor 12 to couple the generator 202 to pump assembly 14.

The main drive for rotor 12 is also shown in FIG. 15. This driveconsists of motor 204 coupled to rotor 12 by drive belt 206.

In operation motor 204 will drive both rotor 12 and pump assembly 14rotating therewith during the separation portion of the above-describedprocesses. However, upon application of brake or mechanism 201, pumpassembly 14 will stop rotation while rotor 12 continues to rotate,possibly at a lower RPM. This relative movement between pump assembly 14and rotor 12 will turn the generator 202 using belt 203 or other drivemechanism. Although a motor belt arrangement is described above, it isrecognized that other known drive mechanisms could be used to providethe energy generation. For example, a gear system could alternatively beused.

FIG. 16 illustrates possible uses of the electricity generated bygenerator 22. For example, such electricity could power one or severallight emitting devices shown at 209 for an optical sensor. It couldalso, alternatively or cumulatively power one or more solenoids 210 forvalving of tubing line 18.

Alternatively the generator could charge a battery 208 for subsequentuse. It is further understood that there may be other uses for thecentrifuge configuration 10 for any electrically generated other thanthose described above. Also, battery 208 can also be mounted on rotor 12and connected to the desired electrical device using elements by knownconnections.

It is understood that a battery 208 could be mounted on rotor 12 withoutgenerator 202 and that such battery can be of the replaceable or therechargeable type. Such battery could provide the necessary electricityneeded for the desired electrical devices.

Other variations (not shown) are also possible including numerousoptions such as, but not limited to, processing unit quantities and/orstructural placements of various containment and/or collection areasand/or channels on the respective rotors and/or relative to each other.Methodology options also abound. Hence, these and various furthermodifications, adaptations and variations of the structure andmethodology of the present invention will become apparent to thoseskilled in the art without departing from the scope or spirit of thepresent invention. It is intended that the present invention cover allsuch modifications, adaptations and variations as limited only by thescope of the following claims and their equivalents.

1. A method for separating a composite fluid into component partscomprising loading the composite fluid into a composite container;providing a rotor with a pump race; placing the composite container withthe composite fluid on the rotor; engaging a central pump mechanism withthe pump race on the rotor; rotating the rotor and the engaged centralpump mechanism together to separate the composite fluid in the compositecontainer; stopping the together rotation of the central pump mechanismand the rotor, and pumping with the central pump mechanism a separatedcomponent part of the composite fluid to a component container after thetogether rotation of the central pump mechanism and the rotor isstopped.
 2. A method according to claim 1 wherein the step of pumpingfurther comprises providing a fluid channel between the compositecontainer and the component container; and moving a separated componentpart from the composite container through the fluid channel to thecomponent container.
 3. A method according to claim 2 further comprisingcollecting the separated component part of the composite fluid.
 4. Amethod according to claim 2 further comprising automatically driving theseparated component part through the fluid channel.
 5. A methodaccording to claim 2 further comprising automatically shutting off theflow of the separated component part through the fluid channel.
 6. Themethod of claim 5 further comprising generating electricity to power theautomatically shutting off step.
 7. A method according to claim 2further comprising automatically capturing an intermediate phasecomponent in a collection area by clamping the flow through the fluidchannel after collection of a separated component part.
 8. A methodaccording to claim 1 further comprising collecting a separated componentpart of the composite fluid; and clamping the flow through the fluidchannel after said step of collecting a separated component part.
 9. Themethod of claim 1 wherein the stopping step further comprises stoppingthe rotation of the central pump mechanism so only the rotor rotates.10. The method of claim 1 wherein the stopping step further compriseschanging the speed of rotation of the central pump mechanism as comparedto the speed of rotation of the rotor to prevent the central pumpmechanism and rotor from rotating together.